A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lun… (NCT05055232) | Clinical Trial Compass
CompletedPhase 1
A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer
China114 participantsStarted 2019-03-12
Plain-language summary
This is a multicenter, open-label, dose escalation, and expansion human clinical study to observe the safety, tolerability, pharmacokinetics, and pharmacodynamics of XZP-3621 in single and multiple oral administrations in advanced NSCLC subjects with ALK rearrangement or ROS1 rearrangement, and to initially explore the efficacy of XZP-3621.The study was divided into two parts: dose escalation and dose expansion.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects aged 18-75 years (including 18 and 75 years);
. Stage IV NSCLC or Stage IIIB and IIIC NSCLC that cannot be treated with radical radiotherapy(IASLC); Dose escalation: ALK rearrangement or ROS1 rearrangement positive, the test specimen and method is not limited;Patients were required to have experienced treatment failure or disease progression after prior ALK inhibitor therapy or were unable to afford ALK inhibitors, regardless of other previous anti-tumor therapies.
. Dose expansion: Subjects must have at least one measurable target lesion as defined by RECIST V1.1 and the lesion has not previously been treated with radiation or has had significant disease progression after radiation therapy;
. All acute toxicities from prior anti-cancer treatment or complications/sequelae from surgical procedures are resolved to baseline or ≤ grade 1 (CTCAE V5.0, hair loss or other toxicities deemed by the investigator to pose no safety risk to the subject);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of adverse events/serious adverse events
Timeframe: From screening stage to 30 days after study completion.
2
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment
. All previous antitumor therapies (including chemotherapy, radiotherapy and immunotherapy) have been stopped for at least 4 weeks before the first administration of XZP-3621 (in which nitrosoreas or mitomycin should be stopped for≥ 6 weeks, and oral small molecule targeted therapy drugs and Chinese medicine (including decoction or Chinese patent medicine) should be stopped for at least 2 weeks);Palliative radiation therapy (irradiation of non-target lesions, local administration of non-target lesions) for the purpose of relieving local symptoms was allowed to be completed one week before study enrollment;
. The expected survival was determined by the investigator to be 12 weeks or more;
. At the time of enrollment, the subject's organ function at baseline was good, and the laboratory data met the following criteria:
Exclusion criteria
. Subjects with primary CNS tumors or symptoms of brain metastases (except those with treated or untreated asymptomatic CNS metastases who had not been treated with corticosteroids for 2 weeks prior to enrollment, stereotactic radiotherapy for 1 week, and whole brain radiotherapy for 2 weeks prior to enrollment);
. subject with small cell lung cancer;
. Malignant thoracic cavity/peritoneal cavity effusion and/or pericardial effusion that cannot be controlled in the dose extension study;
. Prior diagnosis of any other malignancy within 3 years prior to enrollment except for adequately treated and stable basal cell carcinoma or squamous skin cell carcinoma or carcinoma in situ of the cervix;
. Subject has history of hematopoietic stem cell or bone marrow transplantation;
. Subject has history of pancreatitis;
. A history of cerebrovascular accident, including transient ischemic attack or stroke, within 6 months prior to enrollment;
. Major surgery (defined as surgery under general anesthesia or surgery with significant incisions) or unresolved postoperative complications prior to administration of XZP-3621 within 4 weeks prior to enrollment;